An open label, multicentric, phase I/II clinical trial to assess the immunogenicity and safety of Inactivated Influenza Vaccine (Whole Virion) IP, Trivalent in healthy adult subjects

Cadila Healthcare Ltd0 个研究点目标入组 56 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•1.Healthy volunteers of the age 18-60 years age.
•2.If female, not pregnant or lactating at the time of enrolment and not planning pregnancy during the study period.
•3.Subjects likely to be available for all visits during the follow-up period.
•4.Informed consent of the subject/relative

•1.Pregnancy & Lactation.
•2.Subjects with a history of anaphylaxis or serious reactions to vaccines; influenzal viral protein, egg proteins, neomycin or polymyxin.
•3.Subjects who are taking immunostimulant therapy or immunosuppressant medications.
•4.Subjects who are known to be suffering from diseases which can affect immune competence.
•5.Subjects who have received blood products or immunoglobulins parenterally during the preceding 3 months.
•6.Subjects who have recently had acute respiratory pathology or infections requiring systemic antibiotic or antiviral therapy.
•7.Subjects having received influenza vaccine within the previous six months.
•8.Subjects who have received any other vaccine or investigational medicinal product in the preceding 3 months.
•9.Subjects with any other clinically significant concurrent illness.
•10.Subjects with continuing history of alcohol and / or drug abuse

发起方